Dsl Dhea (Dsl 8900)

• • Terminated Z-2882-2011 FDA Unclassified (pre-2012) ·initiated 9 Sep 2010 ·via K921534, on the same 510(k)

  The recall was initiated because Beckman Coulter has confirmed customer reports that DHEA measurements using DHEA RIA (REF DSL-8900) kit lots identified may overstate actual DHEA levels in patient samples.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K921534 ↗

FDA Product Code

JKL

Device Class

Class I

Regulation

21 CFR Part 862.1060

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Dsl Active Shbg (Dsl 7400)

  Class I

  FDA 510(k) K915823 Active Cleared 17 Mar 1992

• Active T3 Ria

  Class II

  FDA 510(k) K960550 Active Cleared 6 Mar 1996

• Dsl Beta 2 Microglobulin (Dsl 6200)

  Class II

  FDA 510(k) K911881 Active Cleared 10 Sep 1991

• Active Crosslaps Elisa

  Class I

  FDA 510(k) K960171 Active Cleared 28 Mar 1996

• Dsl Aactive Dhea Eia Kit

  Class I

  FDA 510(k) K955114 Active Cleared 23 Feb 1996

• Dsl Insulin Ria (Dsl 1600)

  Class I

  FDA 510(k) K914820 Active Cleared 9 Jan 1992

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